A New Pandemic Treaty, Revised International Health Regulations, or Both? What is the Actual Roadmap? Inside View 02/10/2021 • Gian Luca Burci Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) WHO Headquarters in Geneva, Switzerland. The World Health Assembly is set to make a fateful decision in November over whether to negotiate a new international ‘Pandemic Treaty’ to improve future pandemic preparedness and response. However, major players like the United States, backed by some civil society groups, have suggested that revisions of the existing International Health Regulations (IHR) would be a better path. Amidst the hyperbole of oft-heated debate over which route might be easier, quicker or more effective, it’s important to understand that either option will require careful, systematic planning and execution of a process that is oft-misunderstood. At the same time, there are some important technical points that must be kept in mind. WHA agreement to adopt a Pandemic Treaty may have a much more sweeping historical sense, than mere revisions of the existing IHR. But a new treaty will only be enforceable among those member states that have ratified it in what is typically a prolonged process – while any IHR revisions that are agreed to would be applicable to all 196 WHO member states immediately. Ultimately, it is reaching political consensus on the often-charged content of proposed treaty/IHR reforms that matters the most. But to do that, the process also needs careful consideration – and demystification. WHO former legal counsel Gian Luca Burci, Adjunct Professor of international law at the Geneva Graduate Institute, takes apart the procedural issues, and what they mean, ahead of the third working group meeting of member states on the issue, next week. Pandemic Treaty or IHR revisions – exploring the pathways & process In May, the World Health Assembly tasked a Member States’ working group with the critical mission of assessing “the benefits of developing a WHO convention, agreement or other international instrument on pandemic preparedness and response.” The Working Group on Strengthening WHO Preparedness and Response to Health Emergencies (WGPR) is now tasked with coming up with a recommendation in time for a WHA special session in November on whether the WHA should establish an intergovernmental process “to draft and negotiate such a convention, agreement or other international instrument on pandemic preparedness and response.” Just two months from the deadline, we understand that discussions in the WGPR are moving towards negotiating a new “pandemic treaty” and revising the International Health Regulations (IHR) in parallel after the November WHA – rather than forcing a choice between them. While this would be a welcome compromise, there seems to be some confusion, as well as contradictory positions, about the procedural steps required to pursue either option. Debate is particularly intense over the question of whether amending the IHR or concluding a treaty would be “easier and quicker,” and which option would incentivize more participation and commitment. While the process will eventually depend on a number of, as yet, unpredictable factors, international law and practice point to some likely steps and procedural requirements, which are reviewed here. This is without reference to the potential content of a pandemic treaty or amended IHR – closely related to questions of speed and difficulty of negotiations. This review also does not purport to be exhaustive; more information can be found in the Geneva Graduate Institute’s “Guide to a Pandemic Treaty.” Pandemic Treaty – from negotiation to adoption, ratification & entry into force Launch of the negotiating process Under Article 19 of the WHO Constitution, the WHA can adopt “conventions or agreements with respect to any matter within the competence of the Organization.” The process leading up to a WHO treaty (“treaty,” “convention,” “agreement” are different denominations but do not change the substance) would therefore be launched by a WHA resolution. The resolution could shape negotiations, for example by requesting that certain issues be included in the treaty or given priority. However, that level of prescriptiveness is infrequent in contemporary treaty practice to leave flexibility to the negotiators. Negotiating forum The Health Assembly would establish a dedicated intergovernmental body open to all WHO member states to draft and negotiate the future convention. This step can be articulated in many different ways and there is no single model in international practice. In the case of the WHO Framework Convention on Tobacco Control (FCTC), for example, the process was subdivided into two parts: 1) a working group was firstly established to discuss possible building blocks of the convention before committing to treaty negotiations and 2) after a green light from WHA, an intergovernmental negotiating body was established. However, in many other cases, a single body (labelled for example an “intergovernmental negotiating committee”) was responsible for the whole preparation and negotiation of the treaty. This occurred, for example, with the UN Framework Convention on Climate Change (UNFCCC) and later its Kyoto Protocol. WHO Director-General Dr Tedros Adhanom Ghebreyesus delivering the closing speech for the 72nd World Health Assembly in 2019, prior to the COVID-19 pandemic. Negotiating bodies of this nature are invariably open to participation by all member states. In addition, the European Union is a likely invitee with full rights of participation under the rubric of “regional economic integration organizations” (a category that so far includes only the EU). And indeed the EU has already been one of the most vocal advocates of a pandemic treaty. Participation of other non-state actors Beyond member states and possibly the EU, one can expect participation to be extended to other actors identified in the 2016 Framework of Engagement with Non-State Actors, most importantly NGOs, international business associations and philanthropic foundations (the fourth group, academic institutions, are not entitled to participate but are sometimes invited ad hoc as experts). All these actors would participate as “observers” with limited privileges, rather than full negotiators. For example, they usually can only participate in public meetings but are excluded from closed negotiating sessions that often prevail at crucial stages of the process. However, what matters is physical presence at the negotiations to lobby and brief delegates and network with like-minded organizations. Unlike more technical questions such as “one health” and access to pathogen samples, we can expect substantial civil society mobilization and lobbying behind issues such as equity, human rights and access to countermeasures. These considerations are especially relevant if negotiations resume in person; if the sanitary situation still requires online meetings, the process will have to be adapted and the recent sessions of the WHA and the Executive Board offer a blueprint for that. Virtual negotiations of course are less than ideal for all participants. Methods of work – geopolitical representation and the demands of consensus decision-making The body or bodies established by the WHA will have to elect their officers, typically following WHO’s breakdown into six regions. The Assembly can prescribe the make-up of the bureau, as in the case of the WGPR. Appointing the bureau can be a delicate process depending on geopolitical circumstances or competing ambitions. The role of the bureau is not cast in stone but can be decisive for the progress and outcome of work, in particular by working informally behind the scenes to explore options and foster consensus. The bodies concerned will operate under the WHA rules of procedure, but in practice they enjoy considerable discretion in organizing their work. It is customary, and practically a dogma within WHO, that decisions be only taken by consensus without a formal vote. This increases the importance of the process that has to be perceived as fair, legitimate and inclusive to lead to a result that is at least not unacceptable to any state. The requirement of consensus decision-making carries a lot of inertia all the way to the WHA; even though any state can break consensus by formally objecting and requesting a vote, it is in fact a heavy responsibility to do so and it hardly ever happens. Negotiations of long and complex instruments usually require dividing the text, or particularly difficult issues, among subcommittees that work in parallel, formally report to the plenary on their progress and are often coordinated by the bureau. Small delegations have understandable difficulties in managing multiple meetings, and there is an established practice within WHO to avoid more than two parallel meetings. Available UN-system practice, however, shows much flexibility to adapt the organization of work and the mix of formal and informal meetings. Dr Tedros Adhanom Ghebreyesus, WHO Director General, discussing a pandemic treaty in September 2021. Complex WHO intergovernmental negotiations have often been supplemented by intersessional consultations, either on a regional basis or on specific topics. Regional consultations can be particularly effective in reaching common positions and strengthening the negotiating leverage of groups of countries that could otherwise be overpowered individually. Duration and frequency of negotiations are difficult to predict The duration and frequency of treaty negotiations are difficult to predict. The duration of negotiations will depend on a number of factors including the complexity of the issues at hand, the attitude of key countries, the sense of urgency, the diplomatic ability of the bureau, and the intended outcome. A general “framework convention” without detailed and highly prescriptive obligations may be relatively quicker to achieve, but practice shows that even negotiating such instruments requires on average no less than two years. By way of reference, negotiating the UNFCCC took about two years, the FCTC took three years and six negotiating sessions, while its protocol on illicit trade took four years and five sessions. In contrast, negotiating the two IAEA conventions concluded on the heels of the 1986 Chernobyl nuclear accident took just a few months. It is common for the responsible governing body, in our case the WHA, to request progress reports and set a deadline for the conclusion of the negotiations. Even though there are no draconian consequences for not meeting it, it helps focus the negotiations and keep momentum. The frequency of formal meetings usually depends on available financial resources, the capacity of delegations and the secretariat to manage the workload and the calendar of other intergovernmental meetings. One can usually expect no more than two negotiating sessions of 1-2 weeks per year as a maximum. How to get to the initial draft? The initial draft of the treaty is politically and psychologically very important because it inevitably shapes the dynamics of the subsequent negotiations, even for countries opposing it. Even though it is possible for one or more states to come forward with a zero draft text, this is a relatively uncommon step because questions about the motives of the proposing states could affect or derail negotiations. The responsibility to propose a full zero draft therefore can either fall on the chair of the negotiating body (e.g. the FCTC), on the secretariat (e.g. the revised IHR, or in the environmental field the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal, drafted by the UNEP Secretariat). An important point in this regard is that a zero draft does not come out of thin air, but is the result of previous consultations or preparatory work. In the case of the IHR, the draft proposed by the secretariat was the culmination of many years of technical work and consultations, thus the text was submitted promptly to negotiations after a round of regional consultations. In the case of the pandemic treaty, so far there has been no real open discussion on its scope and content either in the WHA or the WGPR, and it is unlikely that this will occur before the WHA special session. Consequently, it is foreseeable that the body established by the WHA will devote an initial period to discuss or seek expert input on the possible building blocks of a treaty and their challenges and implications. Given the uncertainties and questions surrounding the recent proposals, it would be counterproductive to try to short-circuit an inclusive and bottom-up process for achieving a quick result at all costs. Adoption of the treaty and next steps The final draft text would be submitted to the WHA for consideration. As noted above, the Assembly will almost certainly adopt the treaty by consensus. In the unlikely event where consensus could not be reached, Article 19 of the Constitution requires a two-thirds majority (calculated on the basis of valid votes excluding abstentions). The virtual World Health Assembly nerve center at WHO’s Geneva headquarters in May 2020. The upcoming WHA Special Session will likely take a similar form. Other steps that can be taken by the WHA will depend on the nature of the treaty and the conclusions of the negotiations. A pandemic treaty will in all probability be a normative instrument establishing its own governance. Relying on precedents including the FCTC, this will include at a minimum a conference of the parties and a secretariat. Initial work on the institutional aspects will require drafting rules of procedure for the conference of the parties and, depending on the institutional arrangements contained in the treaty, financial regulations and a budget. Even though a treaty is a self-contained instrument and its governance will not be part of WHO’s, the latter may end up providing or hosting its secretariat. For all these reasons, the WHA may establish upon the adoption of the treaty a new intergovernmental body to prepare all the foregoing steps and facilitate the work of the first session of the conference of the parties. Signature, ratification and entry into force Multilateral treaties are customarily opened for signature for a defined period of time. What matters for the entry into force of the treaty, however, is reaching the required number of ratifications (or adherence, accession, formal confirmation depending on the final clauses of the treaty) and how fast that will occur. The threshold for entry into force has varied wildly in previous treaties, anywhere between 20 and 60 as an average (it was 40 for the FCTC and its illicit trade protocol). The number agreed upon will in practice depend on a compromise between an early establishment of the new legal regime and the critical mass of states required to make it credible and effective. A review of UN-system treaties shows on average a time gap of between two and four years between adoption and entry into force; the FCTC protocol on illicit trade took six years, probably reflecting its complexity and demands at national level, but the FCTC took only 21 months. A related consideration for the credibility of the treaty will be the attitude of key states, whether and how quickly they will ratify it and whether they will actively oppose it should they choose to remain outside it. A device occasionally used when it is urgent to start applying a treaty is the so-called “provisional application”, whereby contracting parties indicate in the treaty itself or in a separate act (e.g. the WHA resolution adopting a treaty) that they will provisionally implement the treaty pending its entry into force. A classic but atypical example is the General Agreement on Tariffs and Trade (GATT), provisionally applied from 1947 until 1995. I mention this for the sake of completeness, but it is not a common arrangement for self-intuitive sovereignty concerns. Most of the foregoing considerations also apply to the negotiation and conclusion of protocols to the treaty, should it be drafted as a framework convention requiring separate instruments to spell out its obligations. Albeit linked organically to the “mother convention”, protocols are separate treaties in their own right. Certain steps of the negotiations will probably go faster than for the original convention since the latter provides an applicable legal framework. However, the experience of the FCTC protocol – 10 years from beginning of negotiations to entry into force and only 63 parties so far – should induce caution and deter over-optimism about “quick wins” or “low-hanging fruits.” Strategic reflection is required on whether to make the implementation of a possible pandemic treaty depend heavily on the conclusion of separate protocols. A comparison of the processes required for the creation of a pandemic treaty and revising the International Health Regulations. Amending the International Health Regulations – what is similar or different? The step-by-step process for amending the IHR is spelled out in Article 55. Amendments can be proposed by any state party or the WHO Director-General (DG). Given the direction that the WGPR seems to be taking, it is likely that any amendment process will be launched directly by the Assembly, thus shortening this initial step. The possibility of amending the IHR has arisen, and been controversial within WHO, well before the COVID-19 pandemic. With the exception of a highly-technical 2014 amendment extending the recognised lifetime of yellow fever vaccines, successive IHR Review Committees [expert bodies appointed by the WHO DG] have advised against amendments, and the WHO Secretariat has also traditionally been reluctant to move in this direction. This is due partly to the perceived risk of opening up the entire Regulations to unpredictable and potentially counterproductive revisions that may end up decreasing their credibility and effectiveness. This concern is understandable and legitimate, but, firstly, it applies to any legislative instrument where the risk of unforeseeable outcomes has to be weighed against the need to improve its design and content. Secondly, the WHA can narrow the scope of the amendments by instructing the negotiating body to only deal with specific issues. While this conditionality is infrequent and probably undesirable in the case of treaties, it would be more plausible with regard to the IHR since the Assembly is their parent body and exercises direct oversight functions over them. Similar procedural considerations – but requiring a less steep “learning curve” Most of the procedural considerations involved in the negotiation of a pandemic treaty would apply mutatis mutandis to the amendment of the IHR – and thus are not repeated here. A possible difference concerns the preparatory work preceding and leading to an initial draft of the amendments. The learning curve for a pandemic treaty could be steeper and longer given the absence of an intergovernmental discussion thus far and the lack of familiarity of many delegations. The IHR and its complexities are better known to the public health and foreign affairs officials following WHO affairs, and it is likely that delegations may be willing to move quickly into drafting and negotiations. IHR-specific requirements Article 50 of the IHR provides that the Review Committee shall “make technical recommendations to the Director-General regarding amendments to these Regulations.” The main consideration, time-wise, is whether involving the Review Committee is a compulsory step, since the procedural requirements in the IHR and the way in which they have been implemented by the secretariat so far, are formal and cumbersome and may lead to delays. The second and related consideration is at which stage of the amendment process would the Review Committee intervene? Would it make its recommendations before amendments are drafted, on an initial draft, or rather towards the end of the process? The political implications of those different approaches for the negotiations may be considerable. There are few precedents from which lessons may be learned. The IHR have been amended only once, in 2014, adjusting the requirements for yellow fever vaccination required by some state parties (eg. India) for international travelers arriving from yellow-fever endemic countries (Annex 7). The amendment extended the validity of a well-accepted vaccine from 10 years to lifetime in line with new evidence about the vaccine’s efficacy. An IHR Review Committee was not created for that occasion, setting a precedent. At the same time, the yellow fever vaccine amendment was limited and very technical. It was recommended by the Strategic Advisory Group of Experts on immunization, a dedicated expert group convened by the WHO secretariat, and the WHO Executive Board proposed the amendment to the WHA. In contrast, a broad and substantial amendment of multiple, substantive provisions of the IHR, which might cover sensitive issues around the early warning of outbreaks and WHO’s mandate to investigate and enforce IHR provisions, may be seen as something different legally and politically – warranting the creation of an IHR Review Committee. The possibility of amending the IHR has arisen but the WHO Secretariat has traditionally been reluctant to move in this direction. The main legal consideration is that the Review Committee is an expert body providing its recommendations to the DG at his request rather than a governance organ partaking of the normative functions of WHO. There can be situations like the one just mentioned, in which that technical input is not necessary or can be provided through different and less time-consuming channels. Moreover, a process initiated by the Executive Board or the WHA is different from a proposal by a member state or the DG. In my view, convening a Review Committee may be politically but not legally necessary. It is indicative in this connection that Article 55 does not mention the Review Committee, which suggests that its participation is not compulsory. Adoption of the amendments and entry into force Article 55 requires that amendments be communicated to state parties at least four months before the opening of the WHA, which may influence the schedule of the negotiating body. As noted above, consensus is the norm in WHO, and that will apply to the adoption of the amendments. In the unlikely event of formal objections, a vote would require a simple majority instead of the two-thirds required for a treaty. The main difference between a pandemic treaty and amendments to the IHR concerns entry into force. Pursuant to Article 22 of the Constitution and Article 59 of the IHR, the latter enter into force for all member states 24 months after the DG’s notification of adoption, except for those member states that either reject the amendments or file a reservation within 18 months from that notification. In case of a reservation, Article 62 provides for a rather complex process to determine whether the reservation is compatible with the object and purpose of the Regulations and can be accepted. The Article 62 procedure makes it very difficult in practice to reject a reservation and, historically, the sole objection that I am aware of was by Australia to the 1969 version of the IHR. Opting out of a regulation (or amendments thereof) is a drastic, highly visible and politically heavy decision that states would probably take only for the most serious reasons. Still, both rejections and successful reservations are possible and would undesirably fragment what should be instead a uniform legal and coordinating framework to achieve global health security. Objections could also create impossibly complex situations, e.g. in case of amendments changing the functions of WHO, because objecting states would remain bound by the different functions enshrined in the original IHR. For these reasons and as noted above with regard to a pandemic treaty, the inclusiveness, fairness and legitimacy of the process are of crucial importance to keep states in the fold even if they are not entirely satisfied of the outcome. Conclusions – both exercises can be more or less difficult, depending on the political atmosphere Among the preliminary conclusions that can be drawn is the fact that the two processes, when compared side-by-side, would be substantially similar. However there are some significant differences which will need careful consideration as well. Significantly, amending the IHR may be faster because: 1) modifying an existing text is presumably easier than negotiating one from scratch, 2) the WHA can define and narrow the scope and purpose of the amendments, and 3) WHO member states are relatively familiar with the Regulations. The need to consult the Review Committee, however, must be clarified – as well as what this might mean for achieving consensus. The timeline for entry into force of a treaty or any IHR amendments may be similar for either of the two options, but the amendments to the IHR would enter into force for all 196 WHO member states. In the case of a new treaty, a subset of countries will be bound by it once it enters into force, but the timeline for all WHO member states to ratify such a new instrument could be much more protracted – and remains unknown. Politically, both exercises can be more or less difficult depending on the political atmosphere, the proposals on the table, the ability of the bureau to build consensus and the myriad other factors characterizing any major multilateral negotiation. In both processes, there is great importance in reaching a real and sustainable consensus. At the same time, joining consensus in the WHA to adopt a pandemic treaty is not necessarily predictive of future ratifications since governments as well as circumstances may change. In both cases, finally, it will be important to maintain momentum but avoid imposing unrealistic timelines for the negotiations. The Independent Panel’s call for concluding a pandemic treaty in six months is an example of an unrealistic goal in this connection. Opting into a treaty requires political will and action, which can be highly appealing to politicians. On the other hand, remaining bound by a revised IHR could also be the positive outcome of political inertia and inaction – that is a country’s reluctance to be seen as opting out. The key questions are what is more politically feasible, and what will build more genuine, sustained political commitment to any improved set of international rules that aim to better govern future outbreaks and reduce pandemic risks. Gian Luca Burci is adjunct professor of international law at the Graduate Institute of International and Development Studies. His areas of expertise are global health law and governance, global health security and the law and practice of international organizations. Between 2005 and 2016 he was Legal Counsel of WHO. Updated on 07.10.2021 with a description of the 2014 IHR amendment on requirements around yellow fever vaccines. Image Credits: Flickr – Guilhem Vellut, Flickr – US Mission Geneva, WHO / Antoine Tardy, WHO, Gian Luca Burci, Wikimedia Commons. 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